Tag: clinical trial ethics India

Indian GCP Guidelines vs ICH E6: A Comprehensive Regulatory Comparison

October 2, 2025

Indian GCP Guidelines vs ICH E6: A Comprehensive Regulatory Comparison Understanding the Key Differences Between Indian GCP Guidelines and ICH E6 Introduction Good Clinical Practice (GCP) forms the cornerstone of ethical and scientifically sound clinical research. For stakeholders in India’s clinical trial landscape, two sets of GCP frameworks are critical—India’s own GCP Guidelines (2001) issued…

Clinical Trials in India, Country-Specific Clinical Trials

Ethics Committee Registration Requirements in India

September 20, 2025

digi

Ethics Committee Registration Requirements in India Step-by-Step Guide to Ethics Committee Registration for Indian Clinical Trials Introduction Ethics Committees (ECs) play a critical role in ensuring that clinical trials in India are conducted ethically, safeguarding the rights, safety, and well-being of trial participants. With India’s growing presence in global clinical research, the regulatory framework has…

Clinical Trials in India, Country-Specific Clinical Trials

Ethics Committee Registration with CDSCO: A Complete Regulatory Guide

May 12, 2025

digi

Ethics Committee Registration with CDSCO: A Complete Regulatory Guide How to Register an Ethics Committee with CDSCO: Step-by-Step Compliance Guide In India, the registration of Ethics Committees (ECs) with the Central Drugs Standard Control Organization (CDSCO) is a mandatory regulatory requirement under the New Drugs and Clinical Trials (NDCT) Rules, 2019. Whether institutional or independent,…

CDSCO (India) Guidelines, Regulatory Guidelines